Tragus Stimulation to Prevent Atrial Fibrillation After Cardiac Surgery
キーワード
概要
説明
This is a single-blind study where patients will be randomized tragus stimulation versus sham procedure and remain blinded to their treatment allocation. Both treatment options will utilize similar equipment, namely the use of alligator clips which will be placed on the tragus and earlobe of the right ear for patients. The distinction is only that in patients assigned to tragus stimulation, they will be initiated on therapy at the time of device placement.
Prior to cardiac surgery, the discomfort threshold of both left and righ tragus stimulation will be determined for all participating patients. Intermittent electrode signals, or microcurrents, are delivered at 20 Hz with100 µsec pulse width with variable microampere (mA) output. The discomfort threshold is defined as the stimulation intensity in mA at which point patients experience discomfort. The stimulation intensity used in the study will be set just below the discomfort threshold. The clip will then be placed on the patient's ear at the end of surgery. After surgery is completed, the clip will then be removed and replaced on the opposite ear. Stimulation will then continue, one ear alternating with the other, every 4 hours for a total of 48 hours. It is possible that the threshold can change during the post-operative period. If the patient shows any sign of discomfort from stimulation, the intensity of stimulation will be reduced to a level at which signs of discomfort disappears.
Follow-up will be performed with a 14-day event monitor at the time of discharge. Electrocardiography (ECG) will be performed pre-procedure and prior to hospital discharge. Echocardiography will be assessed prior to study initiation and when clinically available in follow-up.
日付
| 最終確認済み: | 12/31/2019 |
| 最初に提出された: | 01/01/2018 |
| 提出された推定登録数: | 01/01/2018 |
| 最初の投稿: | 01/07/2018 |
| 最終更新が送信されました: | 01/02/2020 |
| 最終更新日: | 01/05/2020 |
| 実際の研究開始日: | 03/08/2018 |
| 一次完了予定日: | 06/30/2020 |
| 研究完了予定日: | 06/30/2020 |
状態または病気
介入/治療
Device: Stimulation Group
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| No Intervention: Sham Group At the end of cardiac surgery, the Parasym alligator clip will be placed on the subject's tragus, but the Parasym will not be turned on and the subject will not receive any stimulation. The clip will be switched to the other ear every 4 hours for a total of 48 hours. | |
| Experimental: Stimulation Group At the end of cardiac surgery, the Parasym alligator clip will be placed on the subject's tragus, and the subject will receive continuous stimulation for 48 hours. The clip will be switched to the other ear every 4 hours. | Device: Stimulation Group Tragus stimulation will be done using the Parasym device. |
適格基準
| 研究の対象となる年齢 | 18 Years に 18 Years |
| 研究に適格な性別 | All |
| 健康なボランティアを受け入れる | はい |
| 基準 | Inclusion Criteria: 1. Patients ≥18 years of age, <90 years of age 2. Estimated life expectancy of at least 1 year at the time of enrollment 3. History of sinus rhythm or paroxysmal atrial fibrillation Exclusion Criteria: 1. Patients ≥90 years of age, <18 years 2. Patients with known prior history of persistent or permanent AF 3. Atrial Fibrillation occurrence within the last 24 hours of procedure 4. Urgent or Emergency cases 5. Pregnant patients 6. Patients undergoing the following cardiac procedures: heart transplant, pulmonary thromboendarterectomy, isolated aortic arch procedures, congenital hear disease, ventricular assist device insertion, extracorporeal membrane oxygenation insertion, and surgical AF ablation 7. Antiarrhythmics prior to surgery (Class I and Class III) 8. High degree atrioventricular block requiring temporary pacing 9. MAZE procedure |
結果
主な結果の測定
1. Time to the first episode of AF >30 seconds [through study completion, an average of 1 month]
2. Extended hospitalization of >5 days [through study completion, an average of 1 month]
二次的な結果の測定
1. Overall AF burden [through study completion, an average of 1 month]
2. Change in inflammatory markers [baseline and 1 month]
3. Actionable AF [through study completion, an average of 1 month]
4. Actionable AF [through study completion, an average of 1 month]
5. Actionable AF [through study completion, an average of 1 month]
6. Actionable AF [through study completion, an average of 1 month]
7. Stroke or transient ischemic attack (TIA) [through study completion, an average of 1 month]
8. All-cause mortality [through study completion, an average of 1 month]
